Calcitonin ELISA - The Calcitonin ELISA is intended for use in the - AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Duns Number:784143778

Device Description: The Calcitonin ELISA is intended for use in the quantitative determination of Calcitonin i The Calcitonin ELISA is intended for use in the quantitative determination of Calcitonin in human serum.

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More Product Details

Catalog Number

21-CALHU-E01

Brand Name

Calcitonin ELISA

Version/Model Number

21-CALHU-E01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K982491

Product Code Details

Product Code

JKR

Product Code Name

Radioimmunoassay, Calcitonin

Device Record Status

Public Device Record Key

548ced1d-ea94-43a5-a3fb-79635d379c87

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 03, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN LABORATORY PRODUCTS COMPANY, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 42
2 A medical device with a moderate to high risk that requires special controls. 23